Renal Fractional Flow Reserve in Renal Artery Stenting (PREFFER)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01128933
First received: May 21, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted

May 21, 2010
May 21, 2010
June 2006
December 2009   (final data collection date for primary outcome measure)
Blood pressure improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Kidney function preservation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Renal Fractional Flow Reserve in Renal Artery Stenting
Prognostic Value of Renal Fractional Flow Reserve in Hypertensive Patients With Renal Artery Stenosis Qualified to Renal Artery Stenting

The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Artery Stenosis
  • Hypertension
Procedure: Renal artery stenting
Experimental: Hypertensive patients
Hypertensive patients with at least moderate renal artery stenosis
Intervention: Procedure: Renal artery stenting
Kądziela J, Januszewicz A, Prejbisz A, Michałowska I, Januszewicz M, Florczak E, Kalińczuk Ł, Norwa-Otto B, Warchoł E, Witkowski A. Prognostic value of renal fractional flow reserve in blood pressure response after renal artery stenting (PREFER study). Cardiol J. 2013;20(4):418-22. doi: 10.5603/CJ.2013.0101.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
May 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography
  • Hypertension defined according to WHO criteria
  • Age 18-75 years
  • Signed informed consent obtained

Exclusion Criteria:

  • Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney
  • Contraindications to percutaneous renal angioplasty with stenting
  • Atrophy of the kidney supplied with stenosed artery
  • Other well known secondary reason for hypertension
  • Chronic heart failure NYHA II-IV
  • Significant valvular heart disease qualified for surgery
  • Persistent atrial fibrillation
  • Renal failure with GFR below 30ml/min
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01128933
2P05B02530
No
Jacek Kadziela, Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
Ministry of Science and Higher Education, Poland
Principal Investigator: Jacek Kadziela, MD,PhD Institute of Cardiology, Warsaw, Poland
Principal Investigator: Adam Witkowski, Prof Institute of Cardiology, Warsaw, Poland
Principal Investigator: Andrzej Januszewicz, Prof Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP